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Cervical PainNCT06751758

Suboccipital Distraction vs. Manual Traction in Chronic Neck Pain

A study testing C1-C2 Mobilization, Transcutaneous Electrical Nerve Stimulation (TENS) and Suboccipital Distraction in people with Cervical Pain, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study addresses the pervasive issue of chronic neck pain, a debilitating condition with profound implications for daily life and well-being. Two therapeutic techniques, suboccipital distraction, and manual traction, are under investigation for their potential to alleviate upper cervical pain and enhance mobility… Read more about this study

Who is it for?
Ages 20 to 40 years
Conditions the study is for
Cervical Pain
What is being tested?
C1-C2 Mobilization, Transcutaneous Electrical Nerve Stimulation (TENS) and Suboccipital Distraction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 sitePakistan
Study dates
15 Jul 2024to 30 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Minimum chronicity: of 3 months chronic neck pain (21)
  • Spurling test (22)

Who cannot join

  • Chronic systemic bony diseases
  • Degenerative joint diseases
  • Psychiatric diseases
  • Recent history of trauma

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Neuro Clinic

    Lahore, Punjab Province, 54782

Other trials in Pakistan

About this study

Official title: Effects of Sub Occipital Distraction Versus Manual Traction on Upper Cervical Pain, Range of Motion and Functional Disability in Chronic Neck Pain

This study addresses the pervasive issue of chronic neck pain, a debilitating condition with profound implications for daily life and well-being. Two therapeutic techniques, suboccipital distraction, and manual traction, are under investigation for their potential to alleviate upper cervical pain and enhance mobility in individuals suffering from chronic neck pain. The primary goal is to compare the effects of these interventions on upper cervical pain, range of motion, and functional disability, providing valuable insights for healthcare professionals to optimize treatment strategies and enhance outcomes in this challenging context. The research adopts a Randomized Clinical Trial (RCT) design to rigorously evaluate the impact of suboccipital distraction and manual traction on upper cervical pain, range of motion, and functional disability in chronic neck pain patients. The Gpower t-test sample size calculation ensures a robust sample size, enhancing statistical power and the validity of findings. Participants will be recruited from Neuro clinic, Lahore, using non-probability convenient sampling. The lottery method will be employed for randomizing participants into suboccipital distraction and manual traction groups, ensuring a balanced distribution of key characteristics. The diverse patient population at Neuro Clinic enhances the generalizability of the study's results. The treatment plan spans 4 weeks, comprising three sessions per week. Each session involves three sets of suboccipital distraction or manual traction, with 5 to 7 repetitions per set. Baseline assessments will be conducted, followed by post-treatment assessments at the 4-week mark. Outcome measures, including standardized pain scales, goniometry for range of motion, and validated instruments for functional disability, will be systematically collected during these intervals.

Read the detailed description

Chronic neck pain is a prevalent and debilitating condition affecting a substantial portion of the global population (1). Among the various therapeutic interventions, suboccipital distraction and manual traction emerge as two distinctive approaches, each holding promise in alleviating upper cervical pain, improving range of motion, and enhancing functional disability (2). The upper cervical region, comprising the atlas and axis vertebrae, plays a crucial role in supporting the head's weight and facilitating complex movements (3). Dysfunction in this area can lead to persistent pain and restricted mobility, warranting effective interventions for improved patient outcomes. This study aims to delve into the comparative effectiveness of suboccipital distraction versus manual traction, exploring their impact on upper cervical pain, range of motion, and functional disability in individuals suffering from chronic neck pain. Chronic neck pain is a multifaceted issue, often stemming from a combination of structural, biomechanical, and psychosocial factors (4). The upper cervical spine is particularly susceptible to dysfunction due to its intricate anatomy and constant engagement in supporting the head's movements. Suboccipital distraction, involving the gentle separation of the atlas and axis vertebrae, has gained attention as a therapeutic technique that targets specific structures in the upper cervical region. On the other hand, manual traction, characterized by the application of force to elongate the cervical spine, is another widely used intervention. Despite the prevalence of these approaches, there is a paucity of research directly comparing their efficacy in the context of chronic neck pain. Understanding the nuanced effects of suboccipital distraction and manual traction is crucial for optimizing treatment strategies and tailoring interventions to individual patient needs. Chronic neck pain is a multifaceted issue that affects a significant portion of the global population, with variations in prevalence across different regions. Studies conducted in Asia have reported a considerable number of individuals suffering from chronic neck pain. For instance, a survey in Japan found that approximately 23% of the population experienced persistent neck pain (5). In Europe, studies indicate varying prevalence rates, with a cross-European investigation estimating the prevalence to be around 15% (6). The situation in North America is also noteworthy, with a study conducted in the United States revealing that about 20% of the adult population reported chronic neck pain lasting more than three months (7). These regional disparities highlight the need for comprehensive research that considers diverse populations. Understanding the prevalence of chronic neck pain in different continents is crucial for contextualizing the importance of interventions such as suboccipital distraction and manual traction. Rationale for this study lies in the need for evidence-based guidance in selecting the most effective intervention for chronic neck pain, especially focusing on the upper cervical region. By comparing the outcomes of suboccipital distraction and manual traction, this research aims to contribute valuable insights into their respective impacts on pain reduction, range of motion improvement, and functional disability alleviation. Such knowledge is essential for clinicians seeking to provide personalized and efficient care to patients grappling with chronic neck pain. Moreover, the comparative effectiveness of these interventions can inform future treatment protocols, guiding healthcare professionals in making informed decisions based on empirical evidence. As the burden of chronic neck pain continues to rise globally, optimizing therapeutic approaches becomes imperative, and this study strives to bridge existing gaps in knowledge, paving the way for more effective and targeted interventions. The significance of this study is underscored by the potential implications for clinical practice and patient outcomes. With chronic neck pain being a widespread and often persistent condition, identifying the most effective intervention can substantially improve the quality of life for affected individuals. Suboccipital distraction and manual traction represent distinct therapeutic modalities, and a direct comparison will offer valuable insights into their relative efficacy.

Conditions
Cervical Pain
Being tested
C1-C2 Mobilization, Transcutaneous Electrical Nerve Stimulation (TENS), Suboccipital Distraction, Traction
Keywords
Cervical pain, Suboccipital Distraction, Manual Traction, Functional disability, Range of motion
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • C1-C2 MobilizationOther

    Participants in both Group A and Group B will receive manual mobilization targeting the C1-C2 region. This specific mobilization technique is chosen for its potential to improve joint mobility and alleviate stiffness in the upper cervical spine. The mobilization will be performed by trained physiotherapists to ensure precision and safety.

  • Transcutaneous Electrical Nerve Stimulation (TENS)Other

    Following C1-C2 mobilization, each participant will undergo a 20-minute session of TENS. TENS involves the application of low-voltage electrical currents through electrodes placed on the skin. This modality aims to modulate pain perception by stimulating nerve fibers, leading to the release of endorphins - the body's natural painkillers. The 20-minute duration is chosen based on established guidelines for effective TENS application.

  • Suboccipital DistractionOther

    Suboccipital distraction is a manual technique aimed at relieving tension in the upper cervical spine. This intervention involves the gentle separation of the suboccipital muscles and associated structures, promoting relaxation and reducing pain. The technique is intended to enhance the range of motion in the cervical region by targeting the upper cervical structures.

    Procedure:

    5-7 repetitions of intermittent distraction 20-30 seconds on, 10-15 seconds off

    Administration:

    Suboccipital distraction will be performed by skilled physiotherapists trained in this technique. Close monitoring will ensure correct application and participant safety.

  • TractionOther

    Traction is a therapeutic technique that involves applying a controlled, manual force to stretch and mobilize the cervical spine. The primary goal of this intervention is to reduce compression on the cervical structures, alleviate pain, and improve the range of motion. It is typically used for its potential to decompress the spine and relieve pressure on nerves.

    Procedure:

    Traction will be administered manually by trained physiotherapists, who will ensure that the correct amount of force is applied and that the treatment is both safe and effective. The application will be carefully tailored to the individual's needs.

    Administration:

    Participants will undergo traction treatments with close monitoring throughout the study period, allowing for necessary adjustments to the treatment plan based on individual responses.

Study groups in NCT06751758
Study groupRoleWhat they receive
Group A - Suboccipital DistractionExperimentalIn addition to the initial conservative treatment phase (cervical spine mobilization targeting the C1-C2 region and a 20-minute session of Transcutaneous Electrical Nerve Stimulation (TENS)), participants in Group A will undergo suboccipital distraction as part of the subsequent intervention. Suboccipital distraction involves the gentle separation of the suboccipital muscles and associated structures to alleviate tension and promote relaxation. This technique specifically targets upper cervical pain and aims to enhance range of motion.
Receives: Other: C1-C2 Mobilization; Other: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Suboccipital Distraction
Group B - TractionActive comparatorAfter the initial conservative treatment phase (cervical spine mobilization targeting the C1-C2 region and a 20-minute session of Transcutaneous Electrical Nerve Stimulation (TENS)), participants in Group B will receive traction as their intervention. Traction involves the application of controlled force to stretch and mobilize the cervical spine manually. The aim is to reduce compression on cervical structures, alleviate pain, and improve the range of motion.
Receives: Other: C1-C2 Mobilization; Other: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Traction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NPRS (Numerical Pain Rating Scale)

    The NPRS is a self-report measure used to assess the intensity of pain experienced by individuals. Participants rate their pain on a numerical scale from 0 (no pain) to 10 (worst possible pain). It is known for its simplicity and ease of administration, making it a practical tool in clinical and research settings.

    Psychometric Properties:

    Validity: Strong convergent validity demonstrated in studies such as Jensen et al. (1986), which compared NPRS with other established pain measures.

    Reliability: The NPRS has been shown to have good test-retest reliability, with consistent pain ratings over time.

    Usefulness: Widely used in clinical settings due to its solid psychometric properties, making it valuable for assessing pain intensity in various populations.

    Measured: baseline, after 4 weeks

  2. Goniometer

    The goniometer is a fundamental tool for objectively measuring joint range of motion (ROM). It consists of a protractor-like device that quantifies the angular displacement of a joint during movement. Validity and reliability of goniometric measurements are crucial to ensure accurate and consistent assessments. Previous research, such as the work by Norkin and White (2009), has supported the concurrent validity of goniometry by comparing its measurements with those obtained through radiographic imaging (25). The goniometer's well-established validity and reliability make it an indispensable tool for assessing joint mobility and tracking changes in range of motion over time.

    Measured: baseline, after 4 weeks

  3. NDI

    This will be used to measure function of neck.Neck disability index was the first tool to measure the self-reported disability in patients with neck pain. It has significant psychometric features and has been shown to be very responsible in clinical trials.

    The index has 10 neck-related functional activities scored on a 0-5 likert scale for each item and total score of 50. Higher score on the scale shows greater disability.

    The NDI has very good reliability (ICC = 0.88;[0.63 to 0.95]) (26, 27).

    Measured: baseline, after 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2024
  2. Study start15 Jul 2024
  3. Primary completion30 Dec 2024
  4. Study completion30 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06751758
Sponsor's protocol ID
Noor Fatima
Status last verified
Jun 2025
First submitted
20 Dec 2024
Last updated
12 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing C1-C2 Mobilization, Transcutaneous Electrical Nerve Stimulation (TENS) and Suboccipital Distraction in people with Cervical Pain, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NPRS (Numerical Pain Rating Scale) (time frame: baseline, after 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.

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